FDA NEEDS MORE OVERSEAS INSPECTORS

Published Online: Tuesday, April 1, 2008

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The FDA is under increasing pressure
from Congress to beef up its foreign
inspections program to improve the safety
of imported medicines, especially
those from China and India—major producers
of active pharmaceutical ingredients
and finished drug products.

The Department of Health and Human
Services recently announced a memorandum
of agreement with China to improve
the safety of imported food, drugs, and
medical devices, but Congress is continuing
to press the issue.

"While I am pleased that [FDA] Commissioner
[Andrew] von Eschenbach has
taken our advice to open FDA offices
overseas," said Rep John Dingell (D, MI),
chairman of the House Energy and
Commerce Committee. "This is just one
step in a long road towards improving
food and drug safety."

Responding to concerns over the FDA's
failure to inspect a Chinese plant manufacturing
1 of the ingredients in the blood
thinner heparin which has been tied to
hundreds of allergic reactions, Dingell
said: "These heparin tragedies are likely
the result of FDA abandoning its preapproval
inspection requirement, a critical
policy that was put in place two decades
ago." He and Rep Bart Stupak (D, MI), who
chairs the Subcommittee on Oversight
and Investigations, are considering emergency
legislation that would prohibit the
marketing of any drug from a plant that
has not been properly inspected.

In March, the FDA received approval
from the State Department to establish 8
full-time, permanent FDA positions at US
diplomatic posts in China, pending
authorization from the Chinese government.